NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1315Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
69238-1315-56923813150569238131505500 CAPSULE in 1 BOTTLE (69238-1315-5)Marketed from Jul 19, 2019
69238-1315-9692381315096923813150990 CAPSULE in 1 BOTTLE (69238-1315-9)Marketed from Jul 19, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Pregabalin
Generic name (nonproprietary)
pregabalin
Active ingredients
Pregabalin — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209743
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 69238-1315_80e6a2ec-3378-4160-aa74-2a7deff71e91SPL ID 80e6a2ec-3378-4160-aa74-2a7deff71e91SPL set ID 3d9d7123-5886-4b61-a7ea-471b213e77d9RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0369238131291, 0369238131796, 0369238131192, 0369238131451, 0369238131758, 0369238131390, 0369238131550, 0369238131697, 0369238131598, 0369238131055, 0369238131659, 0369238131253, 0369238131093, 0369238131154

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469238131505 followed by a unit qualifier and the quantity

Package 69238-1315-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN). (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1315

What is NDC 69238-1315?
69238-1315 is the product NDC for Pregabalin, Pregabalin 200 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pregabalin.
What is the active ingredient?
Pregabalin.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pregabalin?
509 other product NDCs are listed under this name. See all Pregabalin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pregabalin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PregabalinPregabalin 225 mg/1CapsuleOralREMEDYREPACK INC.70518-477870518-4778-00
PregabalinPregabalin 200 mg/1CapsuleOralREMEDYREPACK INC.70518-474970518-4749-00
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-474370518-4743-00
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-471570518-4715-00
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-471670518-4716-00
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44429300-0444-19
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 209743

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209743
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1310
PregabalinPregabalin 50 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1311
PregabalinPregabalin 75 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1312
PregabalinPregabalin 100 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1313
PregabalinPregabalin 150 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1314
PregabalinPregabalin 200 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1315
PregabalinPregabalin 225 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1316
PregabalinPregabalin 300 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1317
PregabalinPregabalin 25 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1310
PregabalinPregabalin 50 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1311
PregabalinPregabalin 75 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1312
PregabalinPregabalin 100 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1313
PregabalinPregabalin 150 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1314
PregabalinPregabalin 225 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1316
PregabalinPregabalin 300 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1317
PregabalinPregabalin 25 mg/1CapsuleOralREMEDYREPACK INC.70518-3974
PregabalinPregabalin 75 mg/1CapsuleOralProficient Rx LP71205-816
PregabalinPregabalin 100 mg/1CapsuleOralDirect_Rx72189-033
PregabalinPregabalin 225 mg/1CapsuleOralDirect_Rx72189-045
PregabalinPregabalin 25 mg/1CapsuleOralDirect_Rx72189-115

Showing 20 of 26.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in